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FDA 510(k)

Zoom 14 Guidewire

K-Number: K201760 · 2020-07-29

ApplicantScientia Vascular, LLC
Decision Date2020-07-29
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Zoom 14 Guidewire is a medical device manufactured by Scientia Vascular, LLC. It received FDA 510(k) clearance on 2020-07-29 under approval number K201760. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zoom 14 Guidewire?

Zoom 14 Guidewire is a medical device that received FDA 510(k) clearance on 2020-07-29. It is manufactured by Scientia Vascular, LLC. The 510(k) number is K201760.

When was Zoom 14 Guidewire approved by the FDA?

Zoom 14 Guidewire received FDA 510(k) clearance on 2020-07-29, under approval number K201760.

What company makes Zoom 14 Guidewire?

Zoom 14 Guidewire is manufactured by Scientia Vascular, LLC.

What is the FDA product code for Zoom 14 Guidewire?

The FDA product code for Zoom 14 Guidewire is DQX.

Other Devices by Scientia Vascular, LLC

K170406Plato MICROCATH 27B Microcatheter K181828Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile K173235Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile K192783Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile K183608Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile K210601Plato 17 Microcatheter

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Related Devices (Code: DQX)

K160785Worker GuidewireArgon Medical Devices, Inc. K161702Endura guidewireVascular Solutions, Inc. K160594MRWire Guide WireNano4imaging GmbH K160643ENROUTE 0.014 GuidewireLake Region Medical K153685Sunmed Haemostatic ValvesSunny Medical Device (Shenzhen) Co., Ltd. K161584ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16Asahi Intecc Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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